ID

33764

Beschreibung

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any recorded rash during the study. It should be filled out everytime a rash occurs during study. A blood sample for PK analysis is to be obtained. Enter details on the “Protocol Deviation Log”

Stichworte

Versionen (2)
  1. 05.12.18 05.12.18 -
  2. 25.12.18 25.12.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

25. Dezember 2018

DOI

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Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Englisch

Record of Rash

1 Formulare  
  1. StudyEvent: ODM
    1. Record of Rash
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschreibung

Subject Screening No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Record of Rash
Beschreibung

Record of Rash

Alias
UMLS CUI-1
C0015230
Has a photograph been taken of the affected area?
Beschreibung

If yes, comment and complete below.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1879646
UMLS CUI [1,2]
C0031749
UMLS CUI [1,3]
C0920316
Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C1879646
UMLS CUI [1,2]
C0031749
UMLS CUI [1,3]
C0920316
UMLS CUI [1,4]
C0947611
Date of Photograph
Beschreibung

Date of Photograph

Datentyp

date

Alias
UMLS CUI [1,1]
C1879646
UMLS CUI [1,2]
C0031749
UMLS CUI [1,3]
C0920316
UMLS CUI [1,4]
C0011008
Actual Time
Beschreibung

Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1879646
UMLS CUI [1,2]
C0031749
UMLS CUI [1,3]
C0920316
UMLS CUI [1,4]
C0040223
Has a punch biopsy sample been collected?
Beschreibung

If yes, comment (include site and number taken).

Datentyp

boolean

Alias
UMLS CUI [1]
C0191321
Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Conclusion
Beschreibung

Conclusion

Alias
UMLS CUI-1
C1707478
Clinical Staff initials
Beschreibung

Clinical Staff initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0871685
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Ähnliche Modelle

Record of Rash

1 Formulare
  1. StudyEvent: ODM
    1. Record of Rash
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Item Group
Record of Rash
C0015230 (UMLS CUI-1)
Affected Area Photographed
Item
Has a photograph been taken of the affected area?
boolean
C1879646 (UMLS CUI [1,1])
C0031749 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,3])
Comment
Item
Comment
text
C1879646 (UMLS CUI [1,1])
C0031749 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Date of Photograph
Item
Date of Photograph
date
C1879646 (UMLS CUI [1,1])
C0031749 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Actual Time
Item
Actual Time
time
C1879646 (UMLS CUI [1,1])
C0031749 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Punch Biopsy Sample
Item
Has a punch biopsy sample been collected?
boolean
C0191321 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Clinical Staff initials
Item
Clinical Staff initials
text
C2986440 (UMLS CUI [1,1])
C0871685 (UMLS CUI [1,2])
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